FDA 510(k) Clearances - September 2022
279 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
September 2022 overview
The FDA cleared 279 medical devices in September 2022 through the 510(k) premarket notification pathway. This compares to 255 clearances in August 2022 - an increase of 24 (+9.4%).
General & Plastic Surgery led all specialties with 50 cleared devices. The fastest average review was Anesthesiology at 43 days. The slowest was Hematology at 876 days.
Overall average review time: 192 days, ranging from 1 to 990 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - September 2022
Detailed data
Review time in calendar days from FDA receipt to decision. Source: FDA 510(k) downloadable files.
| Specialty | Cleared | Avg days | Min | Max | vs August |
|---|---|---|---|---|---|
| General & Plastic Surgery | 50 | 228 | 6 | 990 | +17 |
| General Hospital | 46 | 151 | 9 | 533 | +4 |
| Orthopedic | 39 | 195 | 24 | 641 | - |
| Radiology | 33 | 142 | 23 | 493 | +1 |
| Dental | 28 | 202 | 1 | 784 | +7 |
| Neurology | 18 | 187 | 28 | 392 | +9 |
| Cardiovascular | 16 | 216 | 30 | 446 | -9 |
| Gastroenterology & Urology | 16 | 149 | 27 | 447 | +4 |
| Obstetrics & Gynecology | 10 | 149 | 81 | 348 | +8 |
| Ophthalmic | 6 | 259 | 28 | 637 | -1 |
| Microbiology | 3 | 435 | 203 | 672 | -4 |
| Ear, Nose, Throat | 3 | 80 | 24 | 112 | -1 |
| Physical Medicine | 3 | 190 | 67 | 416 | -2 |
| Immunology | 2 | 353 | 237 | 468 | - |
| Pathology | 2 | 407 | 288 | 526 | - |
| Chemistry | 2 | 292 | 241 | 343 | -3 |
| Hematology | 1 | 876 | 876 | 876 | - |
| Anesthesiology | 1 | 43 | 43 | 43 | -5 |
| Total | 279 | 192 | 1 | 990 | +24 |
Key observations
Fastest reviews
The fastest individual clearance took 1 day. Reviews under 5 days typically reflect Special 510(k) submissions for minor modifications to already-cleared devices.
Longest review
The longest individual review reached 990 days. Extended reviews typically indicate additional information requests or complex predicate device questions. The FDA's standard target is 90 days from receipt.
Leading specialty: General & Plastic Surgery
General & Plastic Surgery led September 2022 with 50 clearances - 18% of all monthly clearances.
Review time spread
Hematology posted the highest average at 876 days. Anesthesiology was fastest at 43 days. The gap of 833 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in September 2022 were Arthrex, Inc. (4) , Boston Scientific Corporation (4) , Steris (3) , Sonoscape Medical Corp. (3) and Canon Medical Systems Corporation (2) . Together, these five manufacturers accounted for 16 of the 279 total clearances - 6% of all September activity.
About this data
This report covers FDA 510(k) submissions with a decision date in September 2022 and a valid days-to-decision value. Data is sourced from the FDA 510(k) public files, published on the 5th of each month and in the public domain (17 U.S.C. § 105). Only cleared decisions are counted (SESE, SESK, SESU, SEKD, SESP, SESD, ST, SN).
Maintained by Space Bits, S.L. Not affiliated with or endorsed by the FDA. Verify at accessdata.fda.gov.